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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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Califf Vows Not to Lower or Remove FDA Regulations

Posted 11 January 2016 | By Zachary Brennan

President Barack Obama’s US Food and Drug Administration (FDA) commissioner nominee Robert Califf, who faces a Senate committee vote Tuesday, told legislators in written comments that he does not support the lowering or removal of regulations at FDA, though he previously said they were a barrier to innovation.

In response to questions from Sen. Lamar Alexander (R-TN) last week, following a November hearing in which senators were largely supportive of the former director of the Duke Clinical Research Institute, on whether FDA regulations are a “barrier to disruptive innovation,” Califf said (italics are his): “I have never stated, implied, or argued that the barrier should be lowered or removed.”

And as far as why Califf has used a slide in some of his presentations calling regulation a barrier and why he wrote in 2013 in the New England Journal of Medicine about inefficiencies in clinical trials and monitoring the safety of approved drugs, Califf told senators:

“My purpose in showing this slide in multiple lectures is to explain to audiences that often include students, trainees in fellowship and scientists who are not involved in development of medical products, why the risk and investment in biotechnology is higher than most other industries, i.e., because it is a highly regulated industry, which is in fact a necessary barrier to protect public health.”

Though many of Califf’s responses to Alexander’s questions are simply reiterations of the goals and missions of FDA (touching on everything from food and tobacco regulation to foreign inspections), Califf also outlined some of what he wants to undertake as commissioner for Obama’s final year in office.

Top Reforms

As far as what FDA can do to enable innovation, Califf laid out three priorities:

Reform the clinical trials system via the Quality by Design principle “so that a combination of small, focused trials for precision medicine and very large trials using electronic health records for inclusion of important populations can be conducted at a dramatically lower cost per unit of knowledge.” He points to FDA’s Sentinel Initiative as a “an excellent building block with claims data on over 170 million Americans available to evaluate the safety of drugs and biologics, but the same system with modifications could be used to dramatically reduce the cost of data collection in clinical trials.”

Improve communication between FDA and the scientific community. “In every case where FDA has offered more meetings with sponsors, the opportunity has been over-subscribed. In addition, public-private partnerships have been highly successful in promoting multi-sector dialogue and developing a common view of key issues in medical product development, including the Medical Device Innovation Consortium and the Clinical Trials Transformation Initiative,” Califf said.

And finally, Califf points to increased collaborations between FDA and other federal departments (ie., FDA-National Institutes of Health (NIH) Leadership Council, which focuses on clarifying the biomarker-surrogate-clinical outcome continuum and streamlining clinical trials).

Foreign Inspections

Alexander also raised a pointed question about why FDA has yet to use a new authority enabled under a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA) from 2012 that allows FDA torequest records in advance or in lieu of an inspection, which could help “detect many data integrity issues without having to send inspectors on site, thus improving FDA’s ability to detect violations rapidly and efficiently.”

Califf said it took the agency more than two years after the law took effect to establish procedures in the Staff Manual Guide (SMG) for requesting records in advance or in lieu of an inspection.

“FDA is planning to pilot the use of the authority in advance of a small number of already-planned inspections in 2016, and the Agency will use the results of that effort to inform its strategy on a broader implementation of the authority,” he added.

FDA also expects to use quality metrics (calculated from data collected through this program) to provide “objective measures that, when used with additional internal data, can provide the agency with indicators of the effectiveness of quality systems associated with pharmaceutical manufacturing. These indicators are expected to be a factor in risk-based inspection coverage, which will enable FDA to focus resources on facilities and products that present a greater risk to consumers.”

Drug Imports

Alexander also raised the question (which has been brought up by numerous politicians in recent months looking to cut the cost of the US health care bill) on why FDA doesn’t allow drug imports from Canada.

Califf’s response, like many other FDA officials before him, focuses on the fact that drugs that are not FDA-approved nor manufactured in a facility inspected by FDA “do not have the assurance of safety, effectiveness, and quality as do drugs subject to FDA oversight. There have been documented incidences of non-FDA-approved imported drugs found to be contaminated, counterfeit, containing varying amounts of active ingredients or none at all, or containing different ingredients than the FDA-approved product.”

He added that an agency evaluation of non-FDA-approved imported drugs revealed that “while nearly half of imported drugs claimed to be Canadian or from Canadian pharmacies, 85 percent of such drugs were actually from different countries. Typically, these products are smuggled into the US after being transshipped to third-party countries in an effort to avoid detection and create an appearance of coming through countries that consumers may find trustworthy.”

The Senate Committee on Health, Education Labor & Pensions is set to vote on Califf’s nomination on Tuesday at 10 a.m.